24-Week Clinical Trial Reports Favourable Safety Profile for Standardised Ashwagandha

A multicentre clinical trial involving 1,200 adults has reported that a standardised Ashwagandha root extract was well tolerated when taken daily for 24 weeks. The findings were highlighted by the Ministry of Ayush following publication of the study in Frontiers in Medicine.

The randomised, double-blind, placebo-controlled trial was conducted across seven centres in India by a multidisciplinary research team comprising 45 researchers from nine institutions. Participants were apparently healthy adults between 18 and 70 years of age who had previously received a first, second or booster dose of the COVISHIELD vaccine.

Participants were randomly assigned to receive either 500 mg of a standardised aqueous Ashwagandha root extract each day, equivalent to approximately four grams of raw root powder, or a matching placebo. The intervention continued for 24 weeks, followed by an additional four weeks of monitoring. Of the 1,200 participants enrolled, 1,032 completed the trial.

Throughout the study, researchers monitored several laboratory indicators of liver and kidney function. These included liver enzymes, bilirubin, creatinine and blood urea. The reported values remained within the reference ranges, and the researchers found no evidence of treatment-related liver or kidney injury.

The trial also recorded adverse events during the study period. No serious adverse event was considered to be caused by the Ashwagandha intervention, and no participant discontinued the trial because of an adverse event.

Researchers also examined whether the extract affected the immune response following COVISHIELD vaccination. Virus-neutralising activity remained above 85 per cent in both the Ashwagandha and placebo groups, with no statistically significant difference between them.

The researchers noted that the findings apply specifically to the standardised aqueous extract and dosage evaluated in the trial and should not automatically be extended to every Ashwagandha preparation or formulation.

28-09-2026